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On 23 June 2025, the FDA approved Samsung Bioepis’ sBLA for an unbranded version of Hadlima® (adalimumab-bwwd), biosimilar to AbbVie’s Humira®.

Samsung Bioepis is not the first to offer an unbranded US adalimumab biosimilar, with the FDA approving Celltrion’s sBLA fo...

Several biosimilars are positioned for listing on Australia’s Pharmaceutical Benefits Scheme (PBS) from 1 July 2025, namely: Celltrion’s Steqeyma® (ustekinumab, biosimilar to Janssen’s Stelara®), Viatris’ Nepexto® (etanercept, biosimilar to Pfizer’s Enbrel®), Sandoz’s Tyruk...

On 20 June 2025, Australia’s Pharmaceutical Benefits Scheme (PBS) published its outcomes from the May 2025 PBAC intracycle meeting, with BMS’ Opdivo® (nivolumab) and Yervoy® (ipilimumab) recommended for reimbursement for stage III melanoma and Novartis’ Xolair® (omalizumab)...

On 20 June 2025, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) published the outcome of its June meeting, with positive opinions for aflibercept biosimilars of STADA, Polpharma and Advanz Pharma, and Bio-Thera’s biosimilar ustekinumab...

On 19 June 2025, Australia’s Therapeutic Goods Administration (TGA) updated its online list of prescription medicine registrations to include expanded indications for BMS’ Opdivo® (nivolumab) and Winglore™ (ipilimumab) in combination for the treatment of adult patients with...

On 19 June 2025, the Unified Patent Court (UPC) Court of Appeal issued decisions refusing two rehearing applications by Alexion Pharmaceuticals in proceedings it had brought seeking preliminary injunctions against Amgen and Samsung Bioepis in relation to the sale of their e...

On 19 June 2025, Australia’s Therapeutic Goods Administration (TGA) updated its online list of prescription medicines for evaluation for March, April and May 2025.

Among the applications to be reviewed is MSD’s clesrovimab (MK-1654, approved on 9 June 2025 as Enflons...